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EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735382
Recruitment Status : Completed
First Posted : April 12, 2016
Results First Posted : August 13, 2019
Last Update Posted : September 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based, closed-loop referrals for tobacco cessation from primary care clinics to a state telephone tobacco quitline service can increase the number/percentage of adult tobacco users receiving evidence-based tobacco dependence treatment when compared to paper-based fax referrals. This study also will survey clinic staff to evaluate satisfaction with the referral process.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Tobacco Smoking Behavioral: Tobacco quitline EHR referral Behavioral: Tobacco quitline Fax referral Not Applicable

Detailed Description:

Aim 1: To evaluate the rates of referral of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system. Analyses will address the change in rates of referrals from pre- to post-intervention and the trajectory of referral post-intervention and will reflect per clinic rates.

Aim 2: To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system (quality referrals are defined as ones that result in individuals who enroll in and receive WTQL counseling and/or medication treatment services). Analyses will address the change in referrals from pre- to post-intervention and will reflect per clinic rates.

Aim 3: To examine variation in referral rates across clinics to test the hypothesis that the eReferral system will result in greater consistency in referral in addition to higher rates of referral. Qualitative methods will be used to understand the sources of variation.

Aim 4: To assess clinician and staff satisfaction with the eReferral and paper fax referral systems via self-report questionnaires.

Aim 5: To evaluate smoking abstinence rates of tobacco users who were referred to and accepted services from the WTQL, comparing those who were referred via an EHR-based referral system vs. those referred via a manual paper fax referral system.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of the Electronic Health Record to Deliver Comprehensive Chronic Care Treatment for Smoking: Study 1: the EHR and Fax Referral Study
Actual Study Start Date : September 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: EHR-based referral to quit line

Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.

Intervention: Behavioral: Tobacco quitline EHR referral

Behavioral: Tobacco quitline EHR referral
Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.

Active Comparator: Fax-based referral to quit line

Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication.

Intervention: Behavioral: Tobacco quitline Fax referral

Behavioral: Tobacco quitline Fax referral
Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.

Experimental: EHR-based Clinic Staff
Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.
Behavioral: Tobacco quitline EHR referral
Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.

Active Comparator: Fax-based referral to quit line Clinic Staff
Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.
Behavioral: Tobacco quitline Fax referral
Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.




Primary Outcome Measures :
  1. Number of Participants Referred [ Time Frame: Rates come from cumulative data collected over the course of 6 months. ]
    EHR-based vs. Fax-based rates of referral of adult tobacco users visiting primary care clinics to the tobacco quitline. The rate of referral will be determined by the ratio of total referrals to total smokers identified in the clinic's EHR over a period of 6 months of study observation.


Secondary Outcome Measures :
  1. Number of Participants Meeting Criteria for Quality Referral [ Time Frame: Rates come from cumulative data collected over the course of 6 months. ]
    To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the tobacco quitline. Quality referrals are defined as ones that result in individuals who enroll in and receive tobacco quit line services.

  2. Number of Participants Self-reporting Smoking Abstinence [ Time Frame: 7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line. ]
    To evaluate smoking abstinence rates of tobacco users who were referred to and accepted services from the WTQL, comparing those who were referred via an EHR-based referral system vs. those referred via a manual paper fax referral system.

  3. Change in Global Staff Satisfaction With the Referral Intervention [ Time Frame: Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score ]
    In order to assess clinician and staff satisfaction with the eReferral and paper-based referral systems, a single-item "The steps I need to take to address my patients' tobacco use are efficient and well designed" was administered to healthcare system clinical staff. The response format was 1 = Strongly disagree; 2 = Disagree; 3 = Mildly disagree; 4 = Feel neutral; 5 = Mildly agree; 6 = Agree; 7 = Strongly agree. Higher scores indicate greater satisfaction with the assigned intervention (EHR-based vs Fax-based referral systems). The item is not part of any existing validated scale and was created for purposes of the project; this item was selected from a larger set of items and determined to be the most appropriate measure of overall staff satisfaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Clinic Eligibility:

Inclusion Criteria:

  • The presence of discrete primary care clinical services within the clinic (defined as general internal medicine or family medicine clinical services);
  • At least three primary care clinician providers in the clinic (physicians or nurse practitioners/physician assistants who see patients independently of a physician);
  • A total primary care clinical volume of at least 60 patients each week;
  • An existing EHR requirement for staff to document tobacco use status including smoking status on all adult patients visiting the clinic at every visit;
  • A capacity to enumerate patient visit information including adult patients/month and adult tobacco users/month by clinician and by clinic;
  • A willingness to participate in the proposed research;
  • A lead physician or a clinic manager on site who agree to serve as a clinic champion for the project;
  • Prior use of the fax referral system to refer patients to the Wisconsin Tobacco Quit Line with use data available for the 12 months prior to study launch;
  • A willingness to accept random assignment to either of the two experimental conditions.

Exclusion Criteria:

  • Those clinics not meeting the above criteria (e.g. too small, limited EHR capacity).

(Note: In this study, the clinics are the "subjects" under study. The patients that will be referred by the clinic to the Wisconsin Tobacco Quit Line will be least 18 years old and Cigarette smokers)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735382


Locations
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United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 57311-2027
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michael Fiore, MD, MPH, MBA University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02735382    
Other Study ID Numbers: 2015-0844
1R35CA197573-01 ( U.S. NIH Grant/Contract )
First Posted: April 12, 2016    Key Record Dates
Results First Posted: August 13, 2019
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Wisconsin, Madison:
Translational Medical Research
Clinical Practice Guidelines
Electronic Health Records
Smoking
Tobacco
Quitline